Jakafi Approved for Myelofibrosis

Incyte announced that the FDA has approved Jakafi (ruxolitinib), an oral JAK1 and JAK2 inhibitor, for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. This approval was based on results from two randomized Phase 3 trials (COMFORT-I and COMFORT-II), which demonstrated that patients treated with Jakafi experienced significant reductions in splenomegaly.

The COMFORT-I trial compared Jakafi to placebo in 309 patients with primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. The trial met the primary endpoint, showing that 41.9% of patients treated with Jakafi experienced a ≥35% reduction in spleen volume at 24 weeks, compared with 0.7% of patients taking placebo (P<0.0001). At Week 24, the percentage of patients with ≥50% improvement in the MFSAF Total Symptom Score was 45.9% and 5.3% in patients treated with Jakafi and placebo, respectively (P<0.0001), with a median time to response of less than four weeks.The COMFORT-II trial compared Jakafi to best available therapy in 219 patients with primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. This trial also met the primary endpoint, showing that 28.5% of patients treated with Jakafi experienced a ≥35% reduction in spleen volume at 48 weeks, compared with 0% of patients in the best available therapy arm (P<0.0001).

For more information call (855) 446-2983 or visit www.incyte.com.